Letter to Agendia B.V.
DEPARTMENT OF HEALTH & HUMAN SERVICES |
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Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
April 6, 2005 |
Via Federal Express
Dr. Bernard Sixt
Chief Executive Officer
Agendia B.V.
Slotervaart Hospital
Floor 9D
Louwesweg 6
NL-1066 EC Amsterdam
The Netherlands
Dear Dr. Sixt:
We are writing you because The Food and Drug Administration (FDA)
obtained information from your website, www.agendia.com, and your
December 8, 2004 press release indicating that you intend to distribute
the MammaPrint® diagnostic test in the U.S. Your internet site
and press release state that MammaPrint® is a “diagnostic
test” and can “assess the risk of breast cancer progression….”
Additionally, your internet site and press release state that the
MammaPrint®, “allows the identification of a group of
high risk patients...” and is a “validated 70-gene signature...
that predicts the development of distant metastases.” According
to the press release, “MammaPrint® outperformed all currently-used
standard diagnostic criteria in predicting future development of
distant metastases….” This product appears to be manufactured
and/or commercially distributed by your firm.
Under a United States federal law, known as the Federal Food, Drug
and Cosmetic Act (Act), diagnostic tests may be devices if they
are intended for use in the diagnosis of disease or other conditions
(21U.S.C. 321(h)). In general, the Act requires that manufacturers
of devices obtain FDA clearance or approval before marketing. This
helps protect the public health by ensuring that newly introduced
medical devices are safe and effective or substantially equivalent
to other devices already legally marketed in this country. The kind
of information a manufacturer needs to submit in order to obtain
clearance or approval is described in our web site at: http://www.fda.gov/cdrh/devadvice.
Based on information from your internet site and press release,
FDA is concerned that the MammaPrint® may not be in conformance
with the Act, including the requirements related to marketing clearance
or approval. We invite you to meet with us at your earliest convenience
to discuss the proper regulation of the MammaPrint®. We are
committed to ensuring that any premarket requirements that may result
from this would follow CDRH's approach of using the least burdensome
regulatory tools needed to protect the public heath.
Please contact me, at (240) 276-0484, to set up a meeting. We
look forward to working with you to help provide novel, safe and
effective products to patients and health care providers.
Sincerely yours,
/S/
Steven I. Gutman, M.D., M.B.A.
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health
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